Treximet in Acute Migraine Headache: Assessing Cognitive Function
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported.
The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control.
It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.
| Condition | Intervention |
|---|---|
|
Migraine Headache Cognitive Impairment |
Drug: Treximet Drug: Migraine rescue medication of choice |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function. |
- To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
- To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Treximet, cognitive testing
|
Drug: Treximet
Treximet
Other Name: Sumatriptan succinate 85mg/Naproxen Sodium 500mg
|
|
Placebo Comparator: 2
Placebo, Cognitive testing
|
Drug: Migraine rescue medication of choice
Migraine rescue medication of choice
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Females and male subjects, ages 18-65 inclusive
- Have migraines with or without aura as expressed by the International Headache Society (IHS) criteria for at least six months and at least one attack per month for three months prior to screening
- If female, have an acceptable method of contraception during the study, have no plans to become pregnant and have a negative urine pregnancy test at screening and throughout the study.
- Must be able to follow study protocol including all neuropsychological testing, MEWT assessments and evaluation forms.
- Must be willing and able to provide written informed consent
Exclusion Criteria:
- Have more than 15 headache days per month
- Have hemiplegic or secondary headaches
- Have significant risk factors for cardiovascular or cerebrovascular disease as assessed by the investigator
- Are taking any medication that is contraindicated with a triptan or NSAIDs
- Have any significant concomitant disease
- Have any allergy to triptans, aspirin or NSAIDs
- Have a history of substance abuse, psychiatric illness in the last 5 years
- Are participating or have participated in an investigational drug trial within the last 30 days
Contacts and Locations| Contact: Judith R Button, BS/CRC | 802-447-7577 ext 104 | jbutton@tristateneuro.com |
| Contact: Carol L Gorman, LPN/CCRC | 802-447-7577 ext 108 | cgorman@tristateneuro.com |
| United States, Vermont | |
| The Neurological Research center, Inc | Recruiting |
| Bennington, Vermont, United States, 05201` | |
| Principal Investigator: Keith R Edwards, MD | |
| Principal Investigator: | Keith R Edwards, M.D. | The Neurological Research Center, Inc. |
More Information
Publications:
| Responsible Party: | Keith R. Edwards, M.D., The Neurological Research Center, Inc |
| ClinicalTrials.gov Identifier: | NCT00837044 History of Changes |
| Other Study ID Numbers: | 112488 |
| Study First Received: | February 4, 2009 |
| Last Updated: | February 4, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Cognition Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Sumatriptan Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013